FDA UDI
In Commercial Distribution
🇺🇸 United States
Atlas™ Humeral Nail System
DI: B058AS50561
·
Model: AS5056
·
Orthopedic Designs North America, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Atlas™ Humeral Nail System
- Primary DI
- B058AS50561
- Version / Model
- AS5056
- Catalog Number
- AS-5-056
- Company Name
- Orthopedic Designs North America, Inc.
- Labeler DUNS
- 945518848
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-14
- Public Version
- 2
- Public Version Date
- 2025-02-06
- Public Version Status
- Update
- Public Device Record Key
- 013c12b5-7c7d-4833-8aae-de4773cc2f8c
Device Description
Atlas Humeral Nail System - Atlas Screw Ø5mm x 056mm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | 888.3020 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66947 | Orthopaedic bone screw (non-sliding) | A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B058AS50561 | HIBCC |
Customer Contacts
- Phone
- 888-635-8535
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241484 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 5 | Millimeter | |
| Length | 56 | Millimeter |